MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC EMAX 2 PLUS MOTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number EMAX2PLUS

Device Problems Device Alarm System (1012); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi ¿ (b)(4).

Event Description

It was reported that during pre-surgery testing it was observed that when the motor device was plugged in, the code for overheating was displayed.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the motor device, and the reported condition was confirmed.An assessment was performed, and it was observed that the device showed an e6 error code (overheat warning) when plugged into the console due to the failure in electrical lead/wire, the housing was damaged, and components were missing.It was further determined that the device failed pretest for loctite assessment, motor thermistor assessment, and safety assessment.As the safety assessment test was failed further tests could not be continued for safety reasons.The assignable root cause of these conditions was determined to be due to improper handling, which is user error.

• Brand Name: EMAX 2 PLUS MOTOR
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 14877322
• MDR Text Key: 295694901
• Report Number: 1045834-2022-00800
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00845384002055
• UDI-Public: 00845384002055
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMAX2PLUS
• Device Catalogue Number: EMAX2PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1